The effective date and general compliance date of the revisions to the Federal Policy for the Protection of Human Subjects (the “Common Rule”) has now been delayed by six months, from January 19, 2018 to July 19, 2018. The United States Department of Health and Human Services (“HHS”)’s rule delaying the implementation date was published in the Federal Register on January 22, 2018.
As we have previously blogged here and here, HHS and the other Common Rule agencies published the long-awaited Final Rule revising the Common Rule on January 19, 2017 (the “Final Rule”), during the last days of the Obama Administration. There had been discussion of delaying the implementation of the Final Rule since that time.
This delay gives institutional review boards and institutions engaged in clinical research a short-term reprieve, but they still need to be do the preparatory work now to be ready when the changes go into effect.